In the study, 52 of 4,908 (1.06%) participants taking varenicline had adverse events compared with 27 of 3,308 (0.82%) participants on placebo, while the number of people who died in each group was the same (seven). The majority of study participants were men and averaged less than 45 years of age.
"Among tobacco users varenicline use was associated with a significantly increased risk of serious adverse cardiovascular events greater than 72 percent," the researchers wrote. "These increased risks of adverse cardiovascular events are seen in smokers with or without heart disease."
The researchers noted additional risks of using the drug, found in previous studies, that led to an existing box warning from the FDA risks of depression, agitation and suicidal thoughts.
"People should be concerned," said Sonal Singh, M.D., M.P.H., lead author on the study from Johns Hopkins University Medical Center. "They don't need Chantix to quit and this is another reason to consider avoiding Chantix altogether."
In the paper, the researchers wrote that "clinicians should carefully balance the risk of serious cardiovascular events and other serious neuropsychiatric adverse events associated with varenicline against their known benefits on smoking cessation."
"The sum of all serious adverse effects of Chantix clearly outweigh the most positive effect of the drug in my view," Furberg said. "The time has come for the FDA to withdraw the drug from the market."
|Contact: Jessica Guenzel|
Wake Forest Baptist Medical Center